Chenofalk (Capsules) Instructions for Use

Marketing Authorization Holder

Dr. Falk Pharma GmbH (Germany)

ATC Code

A05AA01 (Chenodeoxycholic acid)

Active Substance

Chenodeoxycholic acid (Rec.INN registered by WHO)

Dosage Form

Chenofalk

Capsules 250 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

25 pcs. – blister packs (2) – cardboard boxes.
25 pcs. – blister packs (4) – cardboard boxes.

Clinical-Pharmacological Group

Drug promoting the dissolution of cholesterol gallstones

Pharmacotherapeutic Group

Remedy for cholelithiasis

Pharmacological Action

A drug that promotes the dissolution of gallstones. Chenodeoxycholic acid is a physiological bile acid of the hepatointestinal recirculation system. It inhibits the synthesis of cholesterol in the liver, which leads to a decrease in the level of cholesterol in the bile. It reduces the lithogenic index of bile and increases the pool of bile acids. It increases the solubility of cholesterol in bile. It causes gradual complete or partial dissolution of cholesterol stones in the gallbladder and ducts.

It quantitatively and qualitatively changes the bile: the volume of secreted bile increases with an increase in the concentration of conjugated bile acids, the ratio of trihydroxycholic and dihydroxycholic bile acids decreases, the concentration of glycocholic acid increases compared to taurocholic acid, and the concentration of phospholipids increases.

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. During enterohepatic circulation, it is metabolized to form lithocholic acid. Metabolites are excreted in the feces.

Indications

Cholesterol gallstones (size not exceeding 15-20 mm) in the gallbladder (no more than half filled with stones), when their removal by surgical or endoscopic methods is impossible.

ICD codes

Dosage Regimen

Take orally with water.

Determine the daily dose based on patient body weight. The recommended daily dose is 15-18 mg/kg.

Divide the total daily dose. Administer in two divided doses – one in the morning and one in the evening.

For a standard adult patient, this typically corresponds to 3-4 capsules (750-1000 mg) taken twice daily.

Do not exceed the maximum daily dose of 1.5 g (six 250 mg capsules).

Continue treatment for the duration prescribed. The full course of therapy to achieve stone dissolution may require 6 to 24 months of continuous treatment.

Monitor therapeutic efficacy and patient tolerance regularly. Perform cholecystography or ultrasonography at 6 and 12 months of therapy to assess stone dissolution.

Discontinue treatment if no reduction in stone size is observed after 12 months.

Adverse Reactions

Rarely diarrhea, attacks of biliary colic, increased levels of transaminases in the blood serum, allergic reactions (itching, skin rash).

Contraindications

Hypersensitivity to chenodeoxycholic acid; calcification of stones, acute cholecystitis, cholangitis, acute and chronic hepatitis, peptic ulcer of the stomach and duodenum in the acute phase, inflammatory diseases of the esophagus, stomach, intestines; ulcerative colitis, malabsorption syndrome; hepatic and/or renal failure; pregnancy.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

During treatment, women of childbearing age should use contraceptive measures.

Use in Hepatic Impairment

Contraindicated for use in acute and chronic hepatitis, hepatic failure.

Use in Renal Impairment

Contraindicated for use in renal failure.

Special Precautions

During treatment, it is necessary to monitor the functional state of the liver.

In patients with obesity, the effectiveness of this drug is lower, therefore, during therapy, one should strive to reduce body weight.

Drug Interactions

With simultaneous use, cholestyramine, colestipol, and aluminum-containing antacids bind chenodeoxycholic acid in the intestine, reducing its clinical effectiveness.

With simultaneous use, Chenodeoxycholic acid enhances the effect of hypoglycemic agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.